Stable thickener formulations

ABSTRACT

Stable thickener formulations and nutritional compositions having the stable thickener formulations are provided. In a general embodiment, the present disclosure provides a stable thickener formulation comprising from about 0.015% to about 0.05% by weight of carrageenan and from about 1.2% to about 4.0% by weight of starch. The stable thickener formulation can be used in nutritional compositions used to treat a variety of physiological conditions.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a divisional application of U.S. Ser. No.13/504,361, filed May 3, 2012, which is a National Stage ofInternational Application No. PCT/US2010/053891, filed on Oct. 25, 2010,which claims priority to U.S. Provisional Patent Application No.61/254,858, filed on Oct. 26, 2009, and U.S. Provisional PatentApplication No. 61/394,368, filed on Oct. 19, 2010, the entire contentsof which are being incorporated herein by reference.

BACKGROUND

The present disclosure generally relates to health and nutrition. Morespecifically, the present disclosure relates to stable thickenerformulations for nutritional compositions.

There are many types of nutritional compositions currently on themarket. Nutritional compositions can be targeted toward certain consumertypes, for example, young, elderly, athletic, etc., based on thespecific ingredients of the nutritional composition. Nutritionalcompositions can also be formulated based on the certain physiologicalconditions that the nutritional compositions are intended to treat orimprove.

Dysphagia is the medical term for the symptom of difficulty inswallowing. Esophageal dysphagia affects a large number of individualsof all ages, but is generally treatable with medications and isconsidered a less serious form of dysphagia. Esophageal dysphagia isoften a consequence of mucosal, mediastinal, or neuromuscular diseases.

Oral pharyngeal dysphagia, on the other hand, is a very seriouscondition and is generally not treatable with medication. Oralpharyngeal dysphagia also affects individuals of all ages, but is moreprevalent in older individuals. Oral pharyngeal dysphagia is often aconsequence of an acute event, such as a stroke, brain injury, orsurgery for oral or throat cancer. In addition, radiotherapy andchemotherapy may weaken the muscles and degrade the nerves associatedwith the physiology and nervous innervations of the swallow reflex. Itis also common for individuals with progressive neuromuscular diseases,such as Parkinson's Disease, to experience increasing difficulty inswallowing initiation.

The consequences of untreated or poorly managed oral pharyngealdysphagia can be severe, including dehydration, malnutrition leading todysfunctional immune response, and reduced functionality, airwayobstruction with solid foods (choking), and airway aspiration of liquidsand semi-solid foods, promoting aspiration pneumonia and/or pneumonitis.Severe oral pharyngeal dysphagia may require nutrition to be supplied bytube feeding.

Mild to moderate oral pharyngeal dysphagia may require the texture offoods to be modified in order to minimize the likelihood of choking oraspiration. This may include the thickening of liquids and/or pureeingof solid foods, both of which have been shown to be the most effectivemeans of preventing choking and aspiration during the eating process.Thickened liquids are designed to have three properties: (i) a morecohesive bolus that can be maintained throughout the action ofswallowing, (ii) slower delivery to the throat, thereby compensating forthe increased period in which the swallowing reflexes prepare for thethickened liquid, and (iii) provide greater density to increaseawareness of the presence of food or liquid bolus in the mouth.

Thickened nutritional formulations can also be used as part of therapiesto treat other physiological conditions or disease such as renalfailure, chronic obstructive pulmonary disorders, malabsorptiondisorders, etc.

SUMMARY

Stable thickener formulations and nutritional compositions having thestable thickener formulations are provided. In a general embodiment, thepresent disclosure provides a nutritional composition including a stablethickener formulation. The stable thickener formulation can includespecific ranges of carrageenan and starch that provide a consistentviscosity of the nutritional composition during an extended storage timeand at different temperatures. By adding carrageenan, the starch levelcan be decreased. Also, the viscosity increase of nutritionalcompositions at refrigerated storage temperatures can be minimized whencarrageenan and/or xanthan is added thereto. The stable thickenerformulations can also include specific amounts of xanthan gum and starchthat provide a stable viscosity. The nutritional composition can be acomplete feeding or an oral nutritional supplement.

In addition, Applicant has found that the amounts of carrageenan and/orxanthan required for a thickener formula depends on the formulation ofthe nutritional composition and the final amount and type of proteintherein. Indeed, Applicant has found that the amounts and type ofproteins found in a nutritional composition can affect the amount ofcarrageenan and starch required for the present thickener formulas, aswill be discussed further below.

In an embodiment, the present disclosure provides a stable thickenerformulation including from about 0.03% to about 0.05% by weight ofcarrageenan and from about 3.45% to about 3.65% by weight of starch. Inan embodiment, the carrageenan is about 0.04% by weight and the starchis about 3.54% by weight. This stable thickener formulation can providea viscosity or consistency similar to honey. The stable thickenerformulation can further include a viscosity, at refrigeratedtemperatures, ranging from about 1100 cps to about 9000 cps, or fromabout 1100 cps to about 6000 cps, or from about 1100 cps to about 4000cps. In another embodiment, a 1.2 cal, 14 g protein formulation couldhave carrageenan in an amount from about 0.02 to about 0.055% and starchin an amount from 1.0 to about 6%. Alternatively, in another embodiment,a 1.5 cal, 18 g protein formulation could have about 0.02% carrageenanor from about 0.015 to about 0.055% carrageenan, and starch in an amountof about 0.5 to about 5%.

In another embodiment, the present disclosure provides a stablethickener formulation including from about 0.1% to about 0.14% by weightof xanthan gum and from about 2.5% to about 2.7% by weight of starch. Inthis embodiment, the xanthan gum is able to thicken a productpre-sterilization, while the resulting product is still thin enough tobe pumped around the manufacturing plant. In another embodiment, thexanthan gum is about 0.12% by weight and the starch is about 2.6% byweight. The stable thickener formulation can further include aviscosity, at refrigerated temperatures, ranging from about 1100 cps toabout 9000 cps, or from about 1100 cps to about 6000 cps, or from about1100 cps to about 4000 cps.

In yet another embodiment, the present disclosure provides a stablethickener formulation including from about 0.03% to about 0.05% byweight of carrageenan and from about 1.7% to about 1.9% by weight ofstarch. In an embodiment, the carrageenan is about 0.04% by weight andthe starch is about 1.8% by weight. This stable thickener formulationcan provide a viscosity or consistency similar to nectar. Again, theseamounts depend on the formulation of a nutritional composition and theamount and type of protein contained therein. Applicant has found thatthe amount and type of protein affects the amount of carrageenan andstarch that should be added to the nutritional composition. For example,a 1.2 cal, 14 g protein formulation could have carrageenan in an amountfrom about 0.02 to about 0.055% and starch in an amount from 1.0 toabout 6%. Alternatively, in another embodiment, a 1.5 cal, 18 g proteinformulation could have about 0.02% carrageenan or from about 0.015 toabout 0.055% carrageenan, and starch in an amount of about 0.5 to about5%.

In still yet another embodiment, the present disclosure provides astable thickener formulation including from about 0.03% to about 0.05%by weight of carrageenan and from about 2.1% to about 2.2% by weight ofstarch. In an embodiment, the carrageenan is about 0.04% by weight andthe starch is about 2.1% by weight.

In another embodiment, the present disclosure provides a stablethickener formulation including from about 0.03% to about 0.05% byweight of carrageenan and from about 2.2% to about 2.5% by weight ofstarch. In an embodiment, the carrageenan is about 0.04% by weight andthe starch is about 2.36% by weight. This stable thickener formulationcan provide a viscosity or consistency similar to honey. Again, theseamounts depend on the formulation of a nutritional composition and theamount and type of protein added thereto. Applicant has found that theamount and type of protein affects the amount of carrageenan and starchadded to the nutritional compositions. For example, in anotherembodiment, a 1.2 cal, 14 g protein formulation could have carrageenanin an amount from about 0.02 to about 0.055% and starch in an amountfrom 1.0 to about 6%. Alternatively, in another embodiment, a 1.5 cal,18 g protein formulation could have about 0.02% carrageenan or fromabout 0.015 to about 0.055% carrageenan, and starch in an amount ofabout 0.5 to about 5%.

In still another embodiment, the present disclosure provides a stablethickener formulation including from about 0.03% to about 0.05% byweight of carrageenan and from about 2.5 to about 2.9% by weight ofstarch.

In an alternative embodiment, the present disclosure provides anutritional composition including one or more nutritional ingredients,from about 0.03% to about 0.05% by weight of carrageenan, and from about3.45% to about 3.65% by weight of starch. In yet another embodiment, thepresent disclosure provides a nutritional composition including one ormore nutritional ingredients, from about 0.1% to about 0.14% by weightof xanthan gum, and from about 2.5% to about 2.7% by weight of starch.

The nutritional compositions can be in a formulation designed for anymammal such as a human or an animal. The active or nutritionalingredients in the nutritional composition can also be provided as amodular product. A modular product can be defined as a method ofdelivering one or more specific nutrients as a supplement and notintended to be used for sole source nutrition. In addition, thenutritional compositions can be shelf stable and exhibit good shelf lifeat ambient or even above ambient temperatures that may be encounteredduring distribution.

The nutritional compositions can include a viscosity ranging from about250 cps to about 15,000 cps on a Brookfield LTV viscometer, or about 50mPa·50 s to about 1750 mPa·50 s by Rheology measurements (e.g., PhysicaRheometer) at product temperatures from about 4° C. to about 25° C., andhave any suitable types of nutritional ingredients. The nutritionalcompositions can also include a viscosity ranging from about 100 mPa·sto about 2500 mPa·s on a Physica Rheometer. The nutritional ingredientscan be one or more carbohydrates and/or one or more fats. The nutritioningredients can also be one or more synbiotics, fish oils,phytonutrients, antioxidants, vitamins, minerals or a combinationthereof.

In an embodiment, the nutritional composition further includes one ormore prebiotics (e.g., dead or alive). The prebiotic can be acacia gum,alpha glucan, arabinogalactans, beta glucan, dextrans,fructooligosaccharides, galactooligosaccharides, galactomannans,gentiooligosaccharides, glucooligosaccharides, guar gum, inulin,isomaltooligosaccharides, lactosucrose, lactulose, levan, maltodextrins,partially hydrolyzed guar gum, pecticoligosaccharides, retrogradedstarch, soyoligosaccharides, sugar alcohols, xylooligosaccharides, or acombination thereof.

In an embodiment, the nutritional composition further includes one ormore probiotics (e.g., dead or alive). The probiotic can be Aerococcus,Aspergillus, Bacteroides, Bifidobacterium, Candida, Clostridium,Debaromyces, Enterococcus, Fusobacterium, Lactobacillus, Lactococcus,Leuconostoc, Melissococcus, Micrococcus, Mucor, Oenococcus, Pediococcus,Penicillium, Peptostrepococcus, Pichia, Propionibacterium,Pseudocatenulatum, Rhizopus, Saccharomyces, Staphylococcus,Streptococcus, Torulopsis, Weissella, or a combination thereof.

In another embodiment, the nutritional composition further includes oneor more amino acids. The amino acid can be isoleucine, alanine, leucine,asparagine, lysine, aspartate, methionine, cysteine, phenylalanine,glutamate, threonine, glutamine, tryptophan, glycine, valine, proline,serine, tyrosine, arginine, histidine or a combination thereof.

In still another embodiment, the present disclosure provides a methodfor treating a medical condition in a patient. The method comprisesadministering to the patient a nutritional composition including atleast one nutritional ingredient, from about 0.03% to about 0.05% byweight of carrageenan, and from about 1.5% to about 3.65% by weight ofstarch, or about 1.5% to about 2.9% by weight of starch, or about 3.45%to about 3.65% by weight of starch.

In an embodiment, the medical condition is dysphagia, renal failure, achronic obstructive pulmonary disorder or a malabsorption disorder. Thepatient can be an elderly person. The patient can also be a pediatricpatient.

In an embodiment, the nutritional composition is in an administrableform such as pharmaceutical formulations, nutritional formulations,dietary supplements, functional foods, beverage products or acombination thereof.

An advantage of the present disclosure is to provide an improvedthickener formulation.

Another advantage of the present disclosure is to provide a stablethickener formulation at various temperatures that maintains arelatively constant viscosity over an extended period of time.

Yet another advantage of the present disclosure is to provide animproved nutritional composition.

Still another advantage of the present disclosure is to provide a methodof treating or improving an adverse physiological condition in anindividual.

Additional features and advantages are described herein, and will beapparent from the following Detailed Description and the figures.

BRIEF DESCRIPTION OF THE FIGURES

FIG. 1 is graph showing that carrageenan at 0.04% by weight and starchat 3.54% by weight, and carrageenan at 0.02% by weight and starch at2.36% by weight reduces the viscosity difference of a formulationbetween overnight and 3 months storage at 40° F. over other ratios ofcarrageenan and starch in the formula. The stable viscosity was reachedbetween 24 hours and 1 month.

FIG. 2 is a graph showing that carrageenan at 0.04% by weight and starchat 3.54% by weight, and carrageenan at 0.02% by weight and starch at2.36% by weight minimizes the change in viscosity of a formulationbetween 1 month and 3 months storage at 40° F.

FIG. 3 is a graph showing the viscosities of a nutritional compositionhaving a caloric density of 1.2, 14 g of protein and varying amounts ofcarrageenan and starch. The graph shows that carrageenan in an amount ofabout 0.0325% and starch in an amount of at least 1.65% greatlyminimized the change in viscosity of a formulation between 1 month and 3months storage at 40° F.

FIG. 4 is a graph showing the reduction in viscosity increase from roomtemperature storage and refrigerated storage at two months age with theaddition of carrageenan.

FIG. 5 is a graph showing a minimal viscosity increase from roomtemperature to a 24 hour hold at 40° F. when using formulations havingxanthan gum at 0.12% by weight and various amounts of starch.

FIG. 6 is a graph showing the viscosity over time, and at two differenttemperatures, of carrageenan at 0.02% by weight and starch at 1.8% byweight (Prototype A), of carrageenan at 0.02% by weight and starch at2.4% by weight (Prototype B), and xanthan gum at 0.12% by weight andstarch at 2.6% by weight (Prototype C).

FIG. 7 is a graph showing two nutritional composition formulations andthe increase in viscosity of a nutritional composition having 21 g ofprotein as opposed to 18 g of protein; and the increase in viscosity ofa nutritional composition having 1.5% starch as opposed to 2.0% starch.

DETAILED DESCRIPTION

The present disclosure is directed to stable thickener formulations andnutritional compositions having the stable thickener formulations. Thenutritional compositions can be used for the treatment of a variety ofphysiological conditions such as, for example, dysphagia, renal failure,chronic obstructive pulmonary disorders and malabsorption disorders.

As used in this disclosure and the appended claims, the singular forms“a,” “an” and “the” include plural referents unless the context clearlydictates otherwise. Thus, for example, reference to “an amino acid”includes a mixture of two or more amino acids, and the like.

As used herein, “about” is understood to refer to numbers in a range ofnumerals. Moreover, all numerical ranges herein should be understood toinclude all integer, whole or fractions, within the range. All dosageranges contained within this application are intended to include allnumbers, whole or fractions, contained within said range.

As used herein the term “amino acid” is understood to include one ormore amino acids. The amino acid can be, for example, alanine, arginine,asparagine, aspartate, citrulline, cysteine, glutamate, glutamine,glycine, histidine, hydroxyproline, hydroxyserine, hydroxytyrosine,hydroxylysine, isoleucine, leucine, lysine, methionine, phenylalanine,proline, serine, taurine, threonine, tryptophan, tyrosine, valine, orcombinations thereof.

As used herein, “animal” includes, but is not limited to, mammals, whichinclude but is not limited to, rodents, aquatic mammals, domesticanimals such as dogs and cats, farm animals such as sheep, pigs, cowsand horses, and humans. Wherein the terms “animal” or “mammal” or theirplurals are used, it is contemplated that it also applies to any animalsthat are capable of the effect exhibited or intended to be exhibited bythe context of the passage.

As used herein, the term “antioxidant” is understood to include any oneor more of various substances such as beta-carotene (a vitamin Aprecursor), vitamin C, vitamin E, and selenium) that inhibit oxidationor reactions promoted by Reactive Oxygen Species (“ROS”) and otherradical and non-radical species. Additionally, antioxidants aremolecules capable of slowing or preventing the oxidation of othermolecules. Non-limiting examples of antioxidants include carotenoids,coenzyme Q10 (“CoQ10”), flavonoids, glutathione Goji (wolfberry),hesperidine, lactowolfberry, lignan, lutein, lycopene, polyphenols,selenium, vitamin A, vitamin B₁, vitamin B₆, vitamin B₁₂, vitamin C,vitamin D, vitamin E, zeaxanthin, or combinations thereof.

As used herein, a “consistent” viscosity refers to a viscosity of aproduct or composition that has minimal variation between the viscosityof the product or composition at room temperature, and the viscosity ofthe product or composition at a refrigerated temperature.

As used herein, “effective amount” is an amount that prevents adeficiency, treats a disease or medical condition in an individual or,more generally, reduces symptoms, manages progression of the diseases orprovides a nutritional, physiological, or medical benefit to theindividual. A treatment can be patient- or doctor-related.

As used herein, “elderly” means a human that is sixty-five years of ageor older, or at least seventy-five yeas of age or older.

While the terms “individual” and “patient” are often used herein torefer to a human, the present disclosure is not so limited. Accordingly,the terms “individual” and “patient” refer to any animal, mammal orhuman having or at risk for a medical condition that can benefit fromthe treatment.

As used herein, non-limiting examples of fish oils includedocosahexaenoic acid (“DHA”) and eicosapentaenoic acid (“EPA”). DHA andEPA may also be present from a non-fish oil source (e.g., algae,modified plants, etc.).

As used herein, “food grade micro-organisms” means micro-organisms thatare used and generally regarded as safe for use in food.

As used herein, “long term administrations” are continuousadministrations for more than 6 weeks.

As used herein, “mammal” includes, but is not limited to, rodents,aquatic mammals, domestic animals such as dogs and cats, farm animalssuch as sheep, pigs, cows and horses, and humans. Wherein the term“mammal” is used, it is contemplated that it also applies to otheranimals that are capable of the effect exhibited or intended to beexhibited by the mammal.

The term “microorganism” is meant to include the bacterium, yeast and/orfungi, a cell growth medium with the microorganism, or a cell growthmedium in which microorganism was cultivated.

As used herein, the term “minerals” is understood to include boron,calcium, chromium, copper, iodine, iron, magnesium, manganese,molybdenum, nickel, phosphorus, potassium, selenium, silicon, tin,vanadium, zinc, or combinations thereof.

“Nutritional compositions,” as used herein, are understood to includeany number of optional additional ingredients, including conventionalfood additives, for example one or more, acidulants, additionalthickeners, buffers or agents for pH adjustment, chelating agents,colorants, emulsifies, excipient, flavor agent, mineral, osmotic agents,a pharmaceutically acceptable carrier, preservatives, stabilizers,sugar, sweeteners, texturizers, and/or vitamins. The optionalingredients can be added in any suitable amount.

As used herein, “phytochemicals” or “phytonutrients” are non-nutritivecompounds that are found in many foods. Phytochemicals are functionalfoods that have health benefits beyond basic nutrition, and are healthpromoting compounds that come from plant sources. As used herein,“Phytochemicals” and “Phytonutrients” refers to any chemical produced bya plant that imparts one or more health benefit on the user.Phytochemicals can be administered by any means, including topically,enterally, and/or parenterally. As used herein, non-limiting examples ofphytochemicals and phytonutrients include those that are i) Phenoliccompounds which include Monophenols (such as: Apiole, Carnosol,Carvacrol, Dillapiole, Rosemarinol); Flavonoids (polyphenols) includingFlavonols (such as: Quercetin, Gingerol, Kaempferol, Myricetin, Rutin,Isorhamnetin), Flavanones (such as: Hesperidin, Naringenin, Silybin,Eriodictyol), Flavones (such as: Apigenin, Tangeritin, Luteolin),Flavan-3-ols (such as: Catechins, (+)-Catechin, (+)-Gallocatechin,(−)-Epicatechin, (−)-Epigallocatechin, (−)-Epigallocatechin gallate(EGCG), (−)-Epicatechin 3-gallate, Theaflavin, Theaflavin-3-gallate,Theaflavin-3′-gallate, Theaflavin-3,3′-digallate, Thearubigins),Anthocyanins (flavonals) and Anthocyanidins (such as: Pelargonidin,Peonidin, Cyanidin, Delphinidin, Malvidin, Petunidin), Isoflavones(phytoestrogens) (such as: Daidzein (formononetin), Genistein (biochaninA), Glycitein), Dihydroflavonols, Chalcones, Coumestans(phytoestrogens), and Coumestrol; Phenolic acids (such as: Ellagic acid,Gallic acid, Tannic acid, Vanillin, Curcumin); Hydroxycinnamic acids(such as: Caffeic acid, Chlorogenic acid, Cinnamic acid, Ferulic acid,Coumarin); Lignans (phytoestrogens), Silymarin, Secoisolariciresinol,Pinoresinol and lariciresinol); Tyrosol esters (such as: Tyrosol,Hydroxytyrosol, Oleocanthal, Oleuropein); Stilbenoids (such as:Resveratrol, Pterostilbene, Piceatannol) and Punicalagins; ii) Terpenes(isoprenoids) which include Carotenoids (tetraterpenoids) includingCarotenes (such as: α-Carotene, β-Carotene, γ-Carotene, δ-Carotene,Lycopene, Neurosporene, Phytofluene, Phytoene), and Xanthophylls (suchas: Canthaxanthin, Cryptoxanthin, Zeaxanthin, Astaxanthin, Lutein,Rubixanthin); Monoterpenes (such as: Limonene, Perillyl alcohol);Saponins; Lipids including: Phytosterols (such as: Campesterol, betaSitosterol, gamma sitosterol, Stigmasterol), Tocopherols (vitamin E),and omega-3, 6, and 9 fatty acids (such as: gamma-linolenic acid);Triterpenoid (such as: Oleanolic acid, Ursolic acid, Betulinic acid,Moronic acid); iii) Betalains which include Betacyanins (such as:betanin, isobetanin, probetanin, neobetanin); and Betaxanthins (nonglycosidic versions) (such as: Indicaxanthin, and Vulgaxanthin); iv)Organosulfides which include Dithiolthiones (isothiocyanates) (such as:Sulphoraphane); and Thiosulphonates (allium compounds) (such as: Allylmethyl trisulfide, and Diallyl sulfide), Indoles, glucosinolates whichinclude Indole-3-carbinol; sulforaphane; 3,3′-Diindolylmethane;Sinigrin; Allicin; Alliin; Allyl isothiocyanate; Piperine;Syn-propanethial-S-oxide; v) Protein inhibitors which include proteaseinhibitors; vi) Other organic acids which include Oxalic acid, Phyticacid (inositol hexaphosphate); Tartaric acid; and Anacardic acid; orcombinations thereof.

As used herein, a “prebiotic” is a food substance that selectivelypromotes the growth of beneficial bacteria or inhibits the growth ormucosal adhesion of pathogenic bacteria in the intestines. They are notinactivated in the stomach and/or upper intestine or absorbed in thegastrointestinal tract of the person ingesting them, but they arefermented by the gastrointestinal microflora and/or by probiotics.Prebiotics are, for example, defined by Glenn R. Gibson and Marcel B.Roberfroid, Dietary Modulation of the Human Colonic Microbiota:Introducing the Concept of Prebiotics, J. Nutr. 1995 125: 1401-1412.Non-limiting examples of prebiotics include acacia gum, alpha glucan,arabinogalactans, beta glucan, dextrans, fructooligosaccharides,fucosyllactose, galactooligosaccharides, galactomannans,gentiooligosaccharides, glucooligosaccharides, guar gum, inulin,isomaltooligosaccharides, lactoneotetraose, lactosucrose, lactulose,levan, maltodextrins, milk oligosaccharides, partially hydrolyzed guargum, pecticoligosaccharides, resistant starches, retrograded starch,sialooligosaccharides, sialyllactose, soyoligosaccharides, sugaralcohols, xylooligosaccharides, or their hydrolysates, or combinationsthereof.

As used herein, probiotic micro-organisms (hereinafter “probiotics”) arefood-grade microorganisms (alive, including semi-viable or weakened,and/or non-replicating), metabolites, microbial cell preparations orcomponents of microbial cells that could confer health benefits on thehost when administered in adequate amounts, more specifically, thatbeneficially affect a host by improving its intestinal microbialbalance, leading to effects on the health or well-being of the host.See, Salminen S, Ouwehand A. Benno Y. et al., Probiotics: how shouldthey be defined?, Trends Food Sci. Technol. 1999:10, 107-10. In general,it is believed that these micro-organisms inhibit or influence thegrowth and/or metabolism of pathogenic bacteria in the intestinal tract.The probiotics may also activate the immune function of the host. Forthis reason, there have been many different approaches to includeprobiotics into food products. Non-limiting examples of probioticsinclude Aerococcus, Aspergillus, Bacillus, Bacteroides, Bifidobacterium,Candida, Clostridium, Debaromyces, Enterococcus, Fusobacterium,Lactobacillus, Lactococcus, Leuconostoc, Melissococcus, Micrococcus,Mucor, Oenococcus, Pediococcus, Penicillium, Peptostrepococcus, Pichia,Propionibacterium, Pseudocatenulatum, Rhizopus, Saccharomyces,Staphylococcus, Streptococcus, Torulopsis, Weissella, or combinationsthereof.

The terms “protein,” “peptide,” “oligopeptides” or “polypeptide,” asused herein, are understood to refer to any composition that includes, asingle amino acids (monomers), two or more amino acids joined togetherby a peptide bond (dipeptide, tripeptide, or polypeptide), collagen,precursor, homolog, analog, mimetic, salt, prodrug, metabolite, orfragment thereof or combinations thereof. For the sake of clarity, theuse of any of the above terms is interchangeable unless otherwisespecified. It will be appreciated that polypeptides (or peptides orproteins or oligopeptides) often contain amino acids other than the 20amino acids commonly referred to as the 20 naturally occurring aminoacids, and that many amino acids, including the terminal amino acids,may be modified in a given polypeptide, either by natural processes suchas glycosylation and other post-translational modifications, or bychemical modification techniques which are well known in the art. Amongthe known modifications which may be present in polypeptides of thepresent disclosure include, but are not limited to, acetylation,acylation, ADP-ribosylation, amidation, covalent attachment of aflavanoid or a heme moiety, covalent attachment of a polynucleotide orpolynucleotide derivative, covalent attachment of a lipid or lipidderivative, covalent attachment of phosphatidylinositol, cross-linking,cyclization, disulfide bond formation, demethylation, formation ofcovalent cross-links, formation of cystine, formation of pyroglutamate,formylation, gamma-carboxylation, glycation, glycosylation,glycosylphosphatidyl inositol (“GPI”) membrane anchor formation,hydroxylation, iodination, methylation, myristoylation, oxidation,proteolytic processing, phosphorylation, prenylation, racemization,selenoylation, sulfation, transfer-RNA mediated addition of amino acidsto polypeptides such as arginylation, and ubiquitination. The term“protein” also includes “artificial proteins” which refers to linear ornon-linear polypeptides, consisting of alternating repeats of a peptide.

Non-limiting examples of proteins include dairy based proteins, plantbased proteins, animal based proteins and artificial proteins. Dairybased proteins include, for example, casein, caseinates (e.g., all formsincluding sodium, calcium, potassium caseinates), casein hydrolysates,whey (e.g., all forms including concentrate, isolate, demineralized),whey hydrolysates, milk protein concentrate, and milk protein isolate.Plant based proteins include, for example, soy protein (e.g., all formsincluding concentrate and isolate), pea protein (e.g., all formsincluding concentrate and isolate), canola protein (e.g., all formsincluding concentrate and isolate), other plant proteins thatcommercially are wheat and fractionated wheat proteins, corn and itfractions including zein, rice, oat, potato, peanut, green pea powder,green bean powder, and any proteins derived from beans, lentils, andpulses.

As used herein, “short term administrations” are preferably continuousadministrations for less than 6 weeks

As used herein, a “synbiotic” is a supplement that contains both aprebiotic and a probiotic that work together to improve the microfloraof the intestine.

As used herein, the terms “treatment,” “treat” and “to alleviate”include both prophylactic or preventive treatment (that prevent and/orslow the development of a targeted pathologic condition or disorder) andcurative, therapeutic or disease-modifying treatment, includingtherapeutic measures that cure, slow down, lessen symptoms of, and/orhalt progression of a diagnosed pathologic condition or disorder; andtreatment of patients at risk of contracting a disease or suspected tohave contracted a disease, as well as patients who are ill or have beendiagnosed as suffering from a disease or medical condition. The termdoes not necessarily imply that a subject is treated until totalrecovery. The terms “treatment” and “treat” also refer to themaintenance and/or promotion of health in an individual not sufferingfrom a disease but who may be susceptible to the development of anunhealthy condition, such as nitrogen imbalance or muscle loss. Theterms “treatment,” “treat” and “to alleviate” are also intended toinclude the potentiation or otherwise enhancement of one or more primaryprophylactic or therapeutic measure. The terms “treatment,” “treat” and“to alleviate” are further intended to include the dietary management ofa disease or condition or the dietary management for prophylaxis orprevention a disease or condition.

As used herein, a “tube feed” is a complete or incomplete nutritionalproduct or composition that is administered to an animal'sgastrointestinal system, other than through oral administration,including but not limited to a nasogastric tube, orogastric tube,gastric tube, jejunostomy tube (“J-tube”), percutaneous endoscopicgastrostomy (“PEG”), port, such as a chest wall port that providesaccess to the stomach, jejunum and other suitable access ports.

As used herein the term “vitamin” is understood to include any ofvarious fat-soluble or water-soluble organic substances (non-limitingexamples include vitamin A, Vitamin B1 (thiamine), Vitamin B2(riboflavin), Vitamin B3 (niacin or niacinamide), Vitamin B5(pantothenic acid), Vitamin B6 (pyridoxine, pyridoxal, or pyridoxamine,or pyridoxine hydrochloride), Vitamin B7 (biotin), Vitamin B9 (folicacid), and Vitamin B12 (various cobalamins; commonly cyanocobalamin invitamin supplements), vitamin C, vitamin D, vitamin E, vitamin K, folicacid and biotin) essential in minute amounts for normal growth andactivity of the body and obtained naturally from plant and animal foodsor synthetically made, pro-vitamins, derivatives, analogs.

The thickener formulations can include specific blends of thickenerssuch as carrageenan, xanthan and starch that maintain a minimum level ofelasticity and viscosity over an extended period of time. The thickenerformulations can provide nutritional compositions with a designatedlevel of a viscosity. For example, the viscosity can be similar tonectar, honey, pudding, etc.

The skilled artisan will appreciate that there are many types ofstarches that may be used in accordance with the present disclosure. Anon-limiting list of possible starches includes, for example, Thin andThick® 99 Starch by A. E. Staley Manufacturing Company, Polartex® 06740by Cargill, Inc., Polartex® 06747 by Cargill Inc., Polartex® 06748 byCargill Inc., CreamTex® by Cargill Inc., Rezista® by Tate & Lyle, andFirm-Tex® by National Starch and Chemical Company.

In an embodiment, the present disclosure provides a stable thickenerformulation including from about 0.03% to about 0.05% by weight ofcarrageenan and from about 3.45% to about 3.65% by weight of starch. Inan embodiment, the carrageenan is about 0.04% by weight and the starchis about 3.54% by weight. The stable thickener formulation can furtherinclude a viscosity ranging from about 4000 cps to about 9000 cps.

In yet another embodiment, the present disclosure provides a stablethickener formulation including from about 0.03% to about 0.05% byweight of carrageenan and from about 1.5% to about 4.0% by weight ofstarch. This stable thickener formulation can provide a viscosity orconsistency similar to nectar.

In an embodiment, the carrageenan is present in an amount from about0.03% to about 0.04% by weight, and the starch is present in an amountfrom about 1.8% to about 2.0% by weight. In an embodiment, thecarrageenan is present in an amount from about 0.03% to about 0.04% byweight, and the starch is present in an amount from about 2.3% to about2.5% by weight. In an embodiment, the carrageenan is present in anamount from about 0.03% to about 0.04% by weight, and the starch ispresent in an amount from about 1.5% to about 1.9% by weight. In anembodiment, the carrageenan is present in an amount from about 0.03% toabout 0.04% by weight, and the starch is present in an amount from about2.1% to about 2.4% by weight. In an embodiment, the carrageenan is about0.04% by weight and the starch is about 1.8% by weight. In anembodiment, the carrageenan is present in an amount of about 0.0325% byweight and the starch is present in an amount from about 1.5% to about1.9%, or from about 2.1% to about 2.4%.

In still another embodiment, the present disclosure provides a stablethickener formulation including from about 0.03% to about 0.05% byweight of carrageenan and from about 2.2% to about 2.5% by weight ofstarch. In an embodiment, the carrageenan is about 0.04% by weight andthe starch is about 2.36% by weight. This stable thickener formulationcan provide a viscosity or consistency similar to honey.

As used herein, the term “stable” means remaining in a state orcondition wherein the viscosity is maintained at a relatively constantlevel (e.g. differing by no more than 15%, preferably not more than 10%)for an extended period of time (e.g., for at least 1 month). Thickenerformulations according to embodiments of the present disclosure can befound to be stable when maintained for at least 1 month, and aregenerally stable from 2 to 3 months or longer.

In another embodiment, the present disclosure provides a stablethickener formulation including from about 0.1% to about 0.14% by weightof xanthan gum and from about 2.5% to about 2.7% by weight of starch. Inan embodiment, the xanthan gum is about 0.12% by weight and the starchis about 2.6% by weight. These stable thickener formulations can includea viscosity ranging from about 1100 cps to about 9000 cps.

In an alternative embodiment, the present disclosure provides a stablenutritional composition including one or more nutritional ingredients,from about 0.03% to about 0.05% by weight of carrageenan, and from about3.45% to about 3.65% by weight of starch. In another embodiment, thenutritional composition includes at least one nutritional ingredient,from about 0.03% to about 0.05% by weight of carrageenan, and from about1.5% to about 4.0% by weight of starch. In yet another embodiment, thenutritional composition includes at least one nutritional ingredient,from about 0.03% to about 0.05% by weight of carrageenan, and from about2.2% to about 2.5% by weight of starch. In another embodiment, thepresent disclosure provides a stable nutritional composition includingat least one nutritional ingredient, from about 0.1% to about 0.14% byweight of xanthan gum, and from about 2.5% to about 2.7% by weight ofstarch.

The thickener formulations can be used as part of prethickenednutritional compositions that have a viscosity that is maintained over aperiod of time (e.g., at least 1, 2 or 3 months or more at refrigerationstorage temperatures). The nutritional compositions can include anysuitable viscosity that is reached and maintained over a specifiedperiod of time such as, for example, at least 1 month, at least 2months, at least 3 months, etc. In an embodiment, the nutritionalcompositions can include a viscosity ranging from about 250 cps to about15,000 cps on a Brookfield LTV viscometer. In another embodiment, thenutritional compositions can include a viscosity ranging from about 1100cps to about 8500 cps. In yet another embodiment, the nutritionalcompositions can include a viscosity ranging from about 4500 cps toabout 8500 cps. In still yet another embodiment, the nutritionalcompositions could have a viscosity ranging from about 50 to about 1750mPa·50 s by Rheology measurements at product temperatures from about 4°C. to about 25° C.

In an embodiment, the nutritional composition further includes a sourceof carbohydrates. Any suitable carbohydrate may be used in the presentnutritional compositions including, but not limited to, sucrose,lactose, glucose, fructose, corn syrup solids, maltodextrin, modifiedstarch, amylose starch, tapioca starch, corn starch or combinationsthereof.

In an embodiment, the nutritional compositions further include a sourceof fat. The source of fat may include any suitable fat or fat mixture.For example, the fat source may include, but is not limited to,vegetable fat (such as olive oil, corn oil, sunflower oil, rapeseed oil,hazelnut oil, soy oil, palm oil, coconut oil, canola oil, lecithins, andthe like) and animal fats (such as milk fat).

In an embodiment, the nutritional composition further includes one ormore prebiotics. As used herein, a prebiotic is a selectively fermentedingredient that allows specific changes, both in the composition and/oractivity in the gastrointestinal microflora, that confers benefits uponhost well-being and health. Non-limiting examples of prebiotics includeacacia gum, alpha glucan, arabinogalactans, beta glucan, dextrans,fructooligosaccharides, galactooligosaccharides, galactomannans,gentiooligosaccharides, glucooligosaccharides, guar gum, inulin,isomaltooligosaccharides, lactosucrose, lactulose, levan, maltodextrins,partially hydrolyzed guar gum, pecticoligosaccharides, retrogradedstarch, soyoligosaccharides, sugar alcohols, xylooligosaccharides, or acombination thereof.

In an embodiment, the nutritional composition further includes one ormore probiotics. As used herein, probiotics are defined asmicroorganisms (e.g., dead or live) that could confer health benefits onthe host when administered in adequate amounts. Non-limiting examples ofprobiotics include Aerococcus, Aspergillus, Bacteroides,Bifidobacterium, Candida, Clostridium, Debaromyces, Enterococcus,Fusobacterium, Lactobacillus, Lactococcus, Leuconostoc, Melissococcus,Micrococcus, Mucor, Oenococcus, Pediococcus, Penicillium,Peptostrepococcus, Pichia, Propionibacterium, Pseudocatenulatum,Rhizopus, Saccharomyces, Staphylococcus, Streptococcus, Torulopsis,Weissella, or a combination thereof. If the probiotics are intended tobe used alive, the probiotics may be added at the time of consumption ofthe nutritional composition by a dry mix packet, an oil suspension, orother methods known in the art for the use of live probiotics.

In another embodiment, the nutritional composition further includes oneor more amino acids. Non-limiting examples of amino acids includeisoleucine, alanine, leucine, asparagine, lysine, aspartate, methionine,cysteine, phenylalanine, glutamate, threonine, glutamine, tryptophan,glycine, valine, proline, serine, tyrosine, arginine, histidine or acombination thereof.

In an embodiment, the nutritional composition further includes one ormore synbiotics, fish oils, phytonutrients and/or antioxidants. As usedherein, a synbiotic is a supplement that contains both a prebiotic and aprobiotic that work together to improve the microflora of the intestine.Non-limiting examples of fish oils include docosahexaenoic acid (“DHA”)and eicosapentaenoic acid (“EPA”). Non-limiting examples ofphytonutrients include flavonoids and allied phenolic and polyphenoliccompounds, terpenoids such as carotenoids, and alkaloids; includingcurcumin, limonin, and quercetin. As used herein the term “antioxidant”is preferably understood to include any one or more of varioussubstances (as beta-carotene (a vitamin A precursor), vitamin C, vitaminE, and selenium) that inhibit oxidation or reactions promoted byReactive Oxygen Species (ROS) and other radical and non-radical species.Additionally, antioxidants are molecules capable of slowing orpreventing the oxidation of other molecules. Non-limiting examples ofantioxidants include carotenoids, coenzyme Q10 (“CoQ10”), flavonoids,glutathione Goji (Wolfberry), hesperidine, Lactowolfberry, lignan,lutein, lycopene, polyphenols, selenium, vitamin A, vitamin B1, vitaminB6, vitamin B12, vitamin C, vitamin D, vitamin E, and combinations.

In an embodiment, the nutritional composition further includes one ormore vitamins and minerals. Non-limiting examples of vitamins includeVitamins A, B-complex (such as B-1, B-2, B-6 and B-12), C, D, E and K,niacin and acid vitamins such as pantothenic acid and folic acid andbiotin. Non-limiting examples of minerals include calcium, iron, zinc,magnesium, iodine, copper, phosphorus, manganese, potassium, chromium,molybdenum, selenium, nickel, tin, silicon, vanadium and boron.

Other optional ingredients can be added to make the nutritionalcomposition sufficiently palatable. For example, the nutritionalcompositions of the present disclosure can optionally includeconventional food additives, such as any of, acidulants, additionalthickeners, buffers or agents for pH adjustment, chelating agents,colorants, emulsifiers, excipient, flavor agent, mineral, osmoticagents, a pharmaceutically acceptable carrier, preservatives,stabilizers, sugar, sweeteners, texturizers, and/or vitamin. Theoptional ingredients can be added in any suitable amount.

In still another embodiment, the present disclosure provides a methodfor treating a medical condition in a patient. The method comprisesadministering to the patient a nutritional composition including atleast one nutritional ingredient, from about 0.03% to about 0.05% byweight of carrageenan, and from about 1.5% to about 4.0% by weight ofstarch.

In an embodiment, the medical condition is dysphagia, renal failure,chronic obstructive pulmonary disorders, malabsorption disorders, etc.The patient can be an elderly person. Alternatively, the patient can beany suitable individual or animal in need of medical therapy.

In an embodiment, the nutritional composition is in an administrableform such as pharmaceutical formulations, nutritional formulations,dietary supplements, functional foods, beverage products or acombination thereof.

An embodiment of the present disclosure is intended to include a stablethickener formulation comprising from about 0.03% to about 0.05% byweight of carrageenan and from about 3.45% to about 3.65% by weight ofstarch; or wherein the carrageenan is about 0.04% by weight and thestarch is about 3.54% by weight; or weight of carrageenan and weight ofstarch in a ratio of about 1:69 to about 1:122; or weight of carrageenanand weight of starch in a ratio about 1:75 to about 1:110.

An embodiment of the present disclosure is intended to include a stablethickener formulation comprising weight of carrageenan and weight ofstarch in a ratio about 1:80 to about 1:100; or weight of carrageenanand weight of starch in a ratio about 1:85 to about 1:90; or weight ofcarrageenan and weight of starch in a ratio about 1:88.5.

An embodiment of the present disclosure is intended to include a stablethickener formulation comprising from about 0.03% to about 0.05% byweight of carrageenan and from about 1.5% to about 4.0% by weight ofstarch; or wherein the carrageenan is about 0.04% by weight and thestarch is about 1.8% by weight.

An embodiment of the present disclosure is intended to include a stablethickener formulation comprising weight of carrageenan and weight ofstarch in a ratio of about 1:34 to about 1:64; or weight of carrageenanand weight of starch in a ratio of about 1:40 to about 1:55; or weightof carrageenan and weight of starch in a ratio of about 1:43 to about1:50; or weight of carrageenan and weight of starch in a ratio of about1:45.

An embodiment of the present disclosure is intended to include a stablethickener formulation comprising from about 0.1% to about 0.14% byweight of xanthan gum and from about 2.5% to about 2.7% by weight ofstarch; or wherein the xanthan gum is about 0.12% by weight and thestarch is about 2.6% by weight.

An embodiment of the present disclosure is intended to include a stablethickener formulation comprising weight of xanthan and weight of starchin a ratio of about 1:18 to about 1:27; or weight of xanthan and weightof starch in a ratio of about 1:20 to about 1:23; or weight of xanthanand weight of starch in a ratio of about 1:21.7.

An embodiment of the present disclosure is intended to include a stablethickener formulation as defined herein wherein the viscosity, atrefrigerated temperatures, ranges from about 1100 cps to about 9000 cps,or from about 1100 cps to about 6000 cps, or from about 1100 cps toabout 4000 cps.

In an embodiment, the present disclosure is intended to include anutritional composition comprising at least one nutritional ingredient,from about 0.015% to about 0.05% by weight of carrageenan, and fromabout 1.2% to about 3.65% by weight of starch.

An embodiment of the present disclosure is intended to include anutritional composition comprising at least one nutritional ingredient,from about 0.03% to about 0.05% by weight of carrageenan, and from about3.45% to about 3.65% by weight of starch; or wherein the carrageenan isabout 0.04% by weight and the starch is about 3.54% by weight.

An embodiment of the present disclosure is intended to include anutritional composition comprising at least one nutritional ingredient,carrageenan and starch, wherein the weight of carrageenan and weight ofstarch in a ratio of about 1:69 to about 1:122; or the weight ofcarrageenan and weight of starch in a ratio of about 1:75 to about1:110; or wherein the weight of carrageenan and weight of starch in aratio of about 1:80 to about 1:100; or wherein the weight of carrageenanand weight of starch in a ratio of about 1:85 to about 1:90; or whereinthe weight of carrageenan and weight of starch in a ratio of about1:88.5.

An embodiment of the present disclosure is intended to include a stablethickener formulation comprising from about 0.03% to about 0.05% byweight of carrageenan and from about 2.2% to about 2.5% by weight ofstarch; or wherein the carrageenan is about 0.04% by weight and thestarch is about 2.36% by weight.

An embodiment of the present disclosure is intended to include anutritional composition comprising at least one nutritional ingredient,from about 0.03% to about 0.05% by weight of carrageenan, and from about1.7% to about 1.9% by weight of starch; or about 0.03% to about 0.05% byweight of carrageenan, and from about 2.2% to about 2.5% by weight ofstarch.

An embodiment of the present disclosure is intended to include anutritional composition comprising at least one nutritional ingredient,carrageenan and starch, wherein the weight of carrageenan and weight ofstarch in a ratio of about 1:34 to about 1:64; or wherein the weight ofcarrageenan and weight of starch in a ratio of about 1:40 to about 1:55;or wherein the weight of carrageenan and weight of starch in a ratio ofabout 1:43 to about 1:50; or wherein the weight of carrageenan andweight of starch in a ratio of about 1:45.

An embodiment of the present disclosure is intended to include anutritional composition comprising at least one nutritional ingredient,from about 0.1% to about 0.14% by weight of xanthan gum and from about2.5% to about 2.7% by weight of starch; or wherein the xanthan gum is0.12% by weight and the starch is 2.6% by weight.

An embodiment of the present disclosure is intended to include anutritional composition comprising at least one nutritional ingredient,xanthan and starch, wherein the weight of xanthan and weight of starchin a ratio of about 1:18 to about 1:27; or wherein the weight of xanthanand weight of starch in a ratio of about 1:20 to about 1:23; or whereinthe weight of xanthan and weight of starch in a ratio of about 1:21.7.

An embodiment of the present disclosure is intended to include anutritional composition as defined herein, wherein the viscosity rangingfrom about 250 cps to about 15,000 cps.

An embodiment of the present disclosure is intended to include anutritional composition as defined herein, wherein the nutritionalingredient comprises at least one of a carbohydrate, a protein and afat.

An embodiment of the present disclosure is intended to include anutritional composition as defined herein, wherein the nutritionalingredient is selected from the group consisting of prebiotics,probiotics, synbiotics, fish oils, phytonutrients, antioxidants,vitamins, minerals and combinations thereof.

An embodiment of the present disclosure is intended to include anutritional composition as defined herein, wherein the nutritionalcomposition is in an administrable form selected from the groupconsisting of pharmaceutical formulations, nutritional formulations,dietary supplements, functional foods, beverage products andcombinations thereof.

An embodiment of the present disclosure is intended to include anutritional composition as defined herein, wherein the nutritionalcomposition is a complete nutritional.

An embodiment of the present disclosure is intended to include anutritional composition as defined herein, wherein the nutritionalcomposition is an incomplete nutritional.

An embodiment of the present disclosure is intended to include anutritional composition as defined herein, wherein the nutritionalcomposition is for long-term administration.

An embodiment of the present disclosure is intended to include anutritional composition as defined herein, wherein the nutritionalcomposition is for short-term administration.

An embodiment of the present disclosure is intended to include a methodfor treating a medical condition in a patient, the method comprisingadministering to the patient a nutritional composition as hereindefined. The medical condition is selected from the group consisting ofdysphagia, renal failure, chronic obstructive pulmonary disorders,malabsorption disorders and combinations thereof. The method is furtherintended to include a patient that is an elderly person.

An embodiment of the present disclosure is intended to include a methodfor providing nutrition to a patient with dysphagia comprisingadministering to the patient a nutritional composition selected asdefined herein. The method is further intended to include those patientswith dysphagia and a medical condition, the medical condition including,but not limited to renal failure, chronic obstructive pulmonarydisorders, malabsorption disorders and combinations thereof.

EXAMPLES

By way of example and not limitation, the following examples areillustrative of various embodiments of the present disclosure. Theformulations below are provided for exemplification only, and they canbe modified by the skilled artisan to the necessary extent, depending onthe special features that are looked for.

Example 1 Nutritional Compositions

Example 1 contains Tables 1 and 2, which provide exemplary formulationsfor thickeners in accordance with embodiments of the present disclosure.

TABLE 1 Nutritional Composition Having a Thickener Formulation % US RDIPer Serving Per Serving Nutrients 237 ml 237 ml Kcalories 286 CaloricDensity (cal/ml) 1.21 Total Protein g 14.0 Fat g 10.0 CHO g 35.0 Fiber g% Energy Protein 20 Fat 31 CHO 49 Vit A (IU) 750 15.0 Vit C (mg) 30 50.0Vit D (IU) 100 25.0 Vit E (IU) 15.0 50.0 Vit K (mcg) 20 25.0 B6 (mg)1.00 50.0 B12 (mcg) 1.2 20.0 Thiamine (mg) 0.3 20.0 Riboflavin (mg)0.425 25.0 Folic Acid (mcg) 100.0 25.0 Pantothenic Acid (mg) 2.0 20.0Choline (mg) 180 Biotin (mcg) 60.0 20.0 Niacin (mg) 5.0 25.0 Calcium(mg) 300 30.0 Iron (mg) 4.5 25.0 Manganese (mg) 0.5 25.0 Chloride (mg)260 7.6 Phosphorus (mg) 150 15.0 Iodine (mcg) 30 20.0 Magnesium (mg) 6015.0 Zinc (mg) 4.5 30.0 Copper (mg) 0.50 25.0 Sodium (mg) 100 4.2Potassium (mg) 230 6.6 Chromium (mcg) 24.0 20.0 Molybdenum (mcg) 18.825.0 Selenium (mcg) 14 20.0

TABLE 2 Nutritional Composition Having a Thickener Formulation and HighProtein Per Serving % US RDI 237 ml Per Serving Nutrients 8 fl. oz. 237ml Kcalories 358 Caloric Density (cal/ml) 1.5 Total Protein g 18.0 Fat g14.0 CHO g 40.0 % Calories from: Protein % 20 Fat % 35 Carbohydrate % 45Vit A (IU) 750 15.0 Vit C (mg) 30 50.0 Vit D (IU) 100 25.0 Vit E (IU)15.0 50.0 Vit K (mcg) 20 25.0 B6 (mg) 1.00 50.0 B12 (mcg) 1.2 20.0Thiamine (mg) 0.3 20.0 Riboflavin (mg) 0.425 25.0 Folic Acid (mcg) 100.025.0 Pantothenic Acid (mg) 2.0 20.0 Choline (mg) 180 Biotin (mcg) 60.020.0 Niacin (mg) 5.0 25.0 Calcium (mg) 300 30.0 Iron (mg) 4.5 25.0Manganese (mg) 0.5 25.0 Chloride (mg) 260 7.6 Phosphorus (mg) 180 18.0Iodine (mcg) 30 20.0 Magnesium (mg) 60 15.0 Zinc (mg) 4.5 30.0 Copper(mg) 0.50 25.0 Sodium (mg) 190 7.9 Potassium (mg) 270 7.7 Chromium (mcg)24.0 20.0 Molybdenum (mcg) 18.8 25.0 Selenium (mcg) 14 20.0

Example 2 Experimental Studies

Example 2 summarizes various experiments that have been performed withthickener formulations of the present disclosure. Applicant hasperformed several experiments to measure viscosities of variousnutritional compositions having different formulations, over time, andat different temperatures (e.g., room temperature and refrigerationtemperature). In general, the experiments have shown that added certainamounts of carrageenan or xanthan and starch can provide nutritionalcompositions with a stable viscosity during extended storage time at thesame temperature and at different temperatures. Specifically, forexample, adding certain amounts of carrageenan or xanthan and starch canminimize viscosity increases in nutritional compositions stored atrefrigerated temperatures. The present experiments have also shown thatthe amount and type of protein contained in the nutritional compositionsand, to some extent, the caloric density of the nutritional compositionscan play a role in determining the amounts of carrageenan or xanthan andstarch required to achieve a minimized viscosity increase in thenutritional compositions.

As discussed above, Applicant has found that the combination ofcarrageenan and starch in specific amounts in nutritional compositionsis able to reduce the difference in viscosity of a formulation overtime. For example, as shown in FIG. 1, nutritional compositions havingcarrageenan at 0.04% by weight and starch at 3.54% by weight, andcarrageenan at 0.02% by weight and starch at 2.36% by weight havereduced viscosity differences between an overnight storage and 3 monthsstorage at 40° F. A similar, yet reduced, effect is achieved with lesseramounts of carrageenan, as is also shown by FIG. 1. The stable viscositywas reached between 24 hours and 1 month. After about 24 hours, thethickener formulation had a viscosity in the range of honey refrigeratedat 40° F. (e.g., less than 9000 cps).

Similarly, and as shown in FIG. 2, carrageenan at 0.04% by weight andstarch at 3.54% by weight resulted in a minimal viscosity change between1 month and 3 months storage at 40° F. As a result, the thickenerformulation maintained a stable viscosity for between 1 and 3 months.This is in direct contrast to the increases in viscosity of nutritionalcompositions having lower amounts of starch and/or lower amounts ofcarrageenan, as is shown by the broken arrows of FIG. 2.

FIG. 3 also shows minimal viscosity increase in a nutritionalcomposition having a caloric density of 1.2, 14 g of protein, andvarying amounts of carrageenan and starch at different temperatures.Specifically, FIG. 3 shows that carrageenan in an amount from at leastabout 0.0325% and starch in an amount from at least about 1.65% greatlyminimizes any change in viscosity of a nutritional compositionformulation between 1 month and 3 months storage at 40° F.

FIGS. 4-6 show the influence of carrageenan and starch on nutritionalcompositions stored at different temperatures. For example, FIG. 4 showsthat the addition of certain amounts of carrageenan to a nutritionalcomposition can reduce a viscosity increase of the nutritionalcomposition when stored at room temperature as opposed to being storedat 40° F. As shown by FIG. 4, a nutritional composition having twostarches and no added carrageenan results in a 22-fold increase inviscosity between storage at room temperature and storage at 40° F. Thesame nutritional composition with one starch and no added carrageenanresults in an 8-fold increase in viscosity between storage at roomtemperature and storage at 40° F. Adding one starch and carrageenan inan amount of 0.02% to the same nutritional composition results in a5-fold increase in viscosity between storage at room temperature andstorage at 40° F. Further, the same nutritional composition with onestarch and 0.04% carrageenan results in only a 4-fold increase inviscosity between storage at room temperature and storage at 40° F. Assuch, FIG. 4 clearly shows that the addition of certain amounts ofcarrageenan and starch to a nutritional composition can minimize theincrease in viscosity of the nutritional composition when stored at roomtemperature versus 40° F.

In addition to carrageenan, xanthan may be added to nutritionalcompositions, along with starch, to reduce viscosity increases duringstorage. For example, FIG. 5 shows a minimal viscosity increase in anutritional composition from room temperature to a 24 hour hold at 40°F. when using xanthan gum at 0.12% by weight and various amounts ofstarch. A mixture of about 0.12% by weight xanthan gum and 2.6% byweight starch can provide a thickened supplement having a honeyconsistency. Tables 3-6 further demonstrate the viscosity changes overtime at various temperatures when using various concentrations ofxanthan gum and starch.

TABLE 3 Viscosity results over time for formulations including 0.295% byweight xanthan gum and 2.36% by weight starch. Percent 0.295 Xanthan informula Percent 2.36 Starch in formula Viscosity cPs Stored at Stored at43° F. for Stored at Time 43° F. 24 hrs 70° F. Pre-Process 480 Day ofBatching Post Process 2300 Day of Batching 24 hrs 5000 2800  2 weeks4500 2900  3 weeks 6500  3 months 6100 3500  4 months 7200 3600

TABLE 4 Viscosity results over time for formulations including 0.12% byweight xanthan gum and 0.75% by weight starch. Percent 0.12 Xanthan informula Percent 0.75 Starch in formula Viscosity cPs Stored at Stored at43° F. for Stored at Time 43° F. 24 hrs 70° F. Pre-Process 200 Day ofBatching Post Process 100 Day of Batching 5 weeks 330 160 90 9 weeks 360

TABLE 5 Viscosity results over time for formulations including 0.12% byweight xanthan gum and 1.5% by weight starch. Percent 0.12 Xanthan informula Percent 1.5 Starch in formula Viscosity cPs Stored at Stored at43° F. for Stored at Time 43° F. 24 hrs 70° F. Pre-Process Day ofBatching Post Process 800 Day of Batching 24 hrs 400 48 hrs 580  5 weeks1080 540 340  9 weeks 1080 340

TABLE 6 Viscosity results over time for formulations including 0.12% byweight xanthan gum and 2.0% by weight starch. Percent 0.12 Xanthan informula Percent 2.0 Starch in formula Viscosity cPs Stored at Stored at43° F. for Stored at Stored at Time 43° F. 24 hrs 70° F. 95° F.Pre-Process 160 Day of Batching Post Process 720 Day of Batching 1 week880 620 2 weeks 940 1 month 1300 2 months 1600 700 3 months 1740 800 960

FIG. 6 shows the viscosity over time, and at different temperatures, ofa nutritional composition having (i) carrageenan at 0.02% by weight andstarch at about 1.8% by weight (“Prototype A”); (ii) carrageenan at0.02% by weight and starch at 2.4% by weight (“Prototype B”); and (iii)xanthan gum at 0.12% by weight and starch at about 2.6% by weight(“Prototype C”). As is shown by FIG. 6, the viscosities of thenutritional composition are generally stable over the 210 day period.

Accordingly, the experiments performed using various concentrations ofnutritional compositions have shown that adding certain amounts ofcarrageenan or xanthan and starch can provide nutritional compositionswith a stable viscosity during extended storage time at the sametemperature and at different temperatures. Specifically, for example,adding certain amounts of carrageenan or xanthan and starch can minimizeviscosity increases in nutritional compositions stored at refrigeratedtemperatures.

As mentioned above, however, the present experiments have also shownthat the amount and type of protein contained in the nutritionalcompositions and, to some extent, the caloric density of the nutritionalcompositions can play a role in determining the amounts of carrageenanor xanthan and starch required to achieve a minimized viscosity increasein the nutritional compositions. For example, FIG. 7 shows viscositymeasurements of two nutritional composition formulations. The firstcomposition on the left two bars of FIG. 7 includes about 0.02%carrageenan and 1.5% starch. The second composition on the right twobars of FIG. 7 includes about 0.02% carrageenan and about 2.0% starch.The bars clearly illustrate the increase in viscosities of the twonutritional compositions having 21 g of protein as opposed to 18 g ofprotein. Further, the bars of FIG. 7 also clearly illustrate the overallincrease in viscosity of a composition having 1.5% starch as opposed to2.0% starch.

It should be understood that various changes and modifications to thepresently preferred embodiments described herein will be apparent tothose skilled in the art. Such changes and modifications can be madewithout departing from the spirit and scope of the present subjectmatter and without diminishing its intended advantages. It is thereforeintended that such changes and modifications be covered by the appendedclaims.

The invention is claimed as follows:
 1. A stable thickener formulationfor use in a nutritional composition comprising from about 0.1% to about0.14% by weight of xanthan gum and from about 2.5% to about 2.7% byweight of starch, and at least one nutritional ingredient, wherein theviscosity of the formulation is from about 1100 cps to about 9000 cps,and wherein the nutritional ingredient comprises at least one ingredientselected from the group consisting of a carbohydrate, a protein, a fat,prebiotics, probiotics, symbiotics, fish oils, phytonutrients,antioxidants, vitamins, minerals and combinations thereof.
 2. The stablethickener formulation of claim 1, wherein the xanthan gum is about 0.12%by weight and the starch is about 2.6% by weight.
 3. A stable thickenerformulation for use in a nutritional composition comprising a weight ofxanthan gum and a weight of starch in a ratio of about 1:18 to about1:27, and at least one nutritional ingredient, wherein the viscosity ofthe formulation is from about 1100 cps to about 9000 cps, and whereinthe nutritional ingredient comprises at least one ingredient selectedfrom the group consisting of a carbohydrate, a protein, a fat,prebiotics, probiotics, symbiotics, fish oils, phytonutrients,antioxidants, vitamins, minerals and combinations thereof.
 4. The stablethickener formulation of claim 3, wherein the weight of xanthan gum andthe weight of starch is in a ratio of about 1:20 to about 1:23.